The ASEAN medical device industry has received a boost with the first step towards formation of ASEAN Federation of Medical Device Industry. Driving this formation are eight medical device industry associations from Thailand, Philippines, Malaysia, Singapore, Indonesia and Myanmar.
The eight associations, namely Thai Medical Device Technology Industry Association, Philippine Association of Medical Device Regulatory Affairs Professionals, Association of Malaysian Medical Industries, Malaysia Medical Device Association, Association of Medical Device Industry (Singapore), Medical Technology Industry Group of Singapore Manufacturers’ Federation, The Association of Entrepreneurs for Laboratory and Health Equipment (Indonesia) and The Myanmar Pharmaceutical and Medical Equipment Entrepreneurs' Association (Myanmar) had affirmed their commitment to advance the medical device industry at a signing of Memorandum of Understanding.
In line with the global harmonization of medical device regulations, ASEAN Federation of Medical Device Industry serves to represent a single and unified voice of the ASEAN medical device industry when dealing with national authorities on regulatory policies and schemes. With harmonization of medical device regulations, it helps our members achieve the twin objectives of promoting ease of trade amongst us as well as enhancing and professionalizing our trade. ASEANMed hope to be leading body in shaping and propelling the industry forward.
The formation of ASEAN Federation of Medical Device Industry was a timely initiative and it signifies a major milestone in the co-operation of the medical device industry in the region. The ASEANMed will work towards achieving harmonized requirements, procedures and standards in the region, it can create a more buoyant medical industry trade through supply of quality, safe and technologically advanced medical products amongst ASEAN member economies. This inevitably helps propel the elevation of standards of healthcare industry in the ASEAN region.
Recognising that harmonization of medical device regulations is instrumental in promoting international trade, driving professional development and commercial success of the industry, ASEAN Federation of Medical Device Industry has identified training as one of the key activities that the members will be working together.
The ASEANMed will contribute towards the advancement of the industry. The establishment of medical device regulatory policies is essential in safeguarding the quality and safety of public health. Therefore, ASEAN Federation of Medical Device Industry is committed to act as a resource support to train regulatory affairs professionals in compliance requirements.
ASEAN Federation of Medical Device Industry aims to be a cohesive voice of our industry when interacting and consulting government agencies on industry issues, policies and standards. ASEAN Federation of Medical Device Industry will therefore be a good platform for information exchange and experience sharing amongst its members and is able to raise collective views to relevant authorities.
This can be translated into faster and wider access to key medical devices and technologies that may drive significant change in healthcare practice - leading to positive outcomes for patients through the more efficient dissemination of medical and surgical options to improve patients’ and their caregiver's lives. At the same time, this can also potentially reduce the country's disease burden and positively impact strained healthcare budgets through important cost-avoidance savings from complications, re-admissions and prolonged hospital stays.
In countries with aging populations and constrained availability of labor, the critical economic benefits of access to better medical treatments through an industry which is better organized to face today's challenges of increased regulatory scrutiny and escalating R&D and product developments costs, cannot be underestimated.
ASEAN Federation of Medical Device Industry welcomes medical device associations from other nations of ASEAN to join its mission in advancing the development of the industry.
About ASEAN Federation of Medical Device Industry
ASEAN Federation of Medical Device Industry represents a come together among Medical Device Industry Associations in the Southeast Asia Region, and it comprises of 7 trade associations namely Thai Medical Device Technology Industry Association, Philippine Association of Medical Device Regulatory Affairs Professionals, Association of Malaysian Medical Industries, Malaysian Medical Device Association, Association of Medical Device Industry (Singapore), Medical Technology Industry Group of Singapore Manufacturers’ Federation and The Association of Entrepreneurs for Laboratory and Health Equipment (Indonesia).
This regional cooperation was formed in retrospect of the ASEAN Medical Device Directive launched with the mutual desire to promote international business cooperation within the region. The working party hinges on agreed collaboration to foster the growth of the medical device industry by enhancing the competitiveness of medical devices through targeted collaborations, without creating legally-binding obligations.
About Thai Medical Device Technology Industry Association (THAIMED)
The Thai Medical Device Technology Industry Association (THAIMED) was established in 1989 and since that time it has accumulated a lot of success stories included its aims to promote high professional standards to ensure the availability of high quality medical devices and services to benefit the health of the Thai people.
During its two decades of existence, THAIMED has built a solid reputation as a smooth-running association that brings together 82 local and international companies linked to the distribution of medical devices in Thailand.
Over the past 23 years, THAIMED has successfully led the industry in these issues despite many initial difficulties in getting all relevant parties to reach a consensus and work together as a single unit.
About Philippine Association of Medical Device Regulatory Affairs Professionals (PAMDRAP)
The Philippine Association of Medical Device Regulatory Affairs Professionals (PAMDRAP) is a non-stock and non-profit association composed of Regulatory Affairs professionals from local and multinational medical device companies.
Its mission is to organize and unite Regulatory Affairs professionals and act as a dialogue partner and resource to government agencies in the seamless implementation of Medical Device regulations in the Philippines. The group aims to enable and empower its members to perform their corporate roles by providing trainings and technical discussions on regulations as well as issues affecting the industry. PAMDRAP also partners with various government agencies to carry out capacity building programs aimed at improving regulatory standards development and compliance of both government and industry.
PAMDRAP is the first and currently the only medical device industry association recognized by the Center for Device Regulation, Radiation Health and Research of the Food and Drug Administration in the Philippines.
About Association of Malaysian Medical Industries (AMMI)
Formed in 1989, the Association of Malaysian Medical Industries (AMMI) consists of leading medical device manufacturing companies in the medical technology industry. AMMI members share a common commitment to quality and are reputable international and local firms that strictly adhere to the quality management system codes laid down by governmental agencies. The AMMI companies continue to be the growth base of the medical device industry in Malaysia and consist of three main types of industry players: manufacturers; suppliers of raw materials and services to the medical devices manufacturing companies; and importers and exporters of medical devices, all of whom employ a sizable workforce in their production facilities.
AMMI also provides a single-minded approach to grow the medical device industry by focusing on strategic initiatives in promoting manufacturing and operational excellence, talent development, support market driven innovation and R & D processes and promote opportunities for developing viable shared services.
About Malaysia Medical Device Association (MMDA)
The Association, a non-profit organisation was incorporated in April 2005 and with a current membership of over 220 is the premier organization representing the interest of the medical device industry players in the country. The formation of this association was consequential to the government’s directive on the regulation of medical device industry and serve as a representative to the Medical Device Authority of the Ministry of Health Malaysia.
About Association of Medical Device Industry (AMDI)
The Association of Medical Device Industry (Singapore) was incorporated in January 2011. AMDI serves as a key representative body for the medical device industry in Singapore. It aims to advocate good practices and promote high industry standards among the trade.
AMDI envisions itself to be a leading Association that will provide a credible platform for the Medical Device Industry to offer Quality, Professional and Networking Resources, as well as to offer a worthy platform to allow members the opportunity to advance and grow in the industry. The Association is committed to act as a credible representative of the Medical Device Industry in Singapore, continuously promoting quality and professionalism for the good of the industry.
About Medical Technology Industry Group of Singapore Manufacturers’ Federation (SMF)
About The Association of Entrepreneurs for Laboratory and Health Equipment (GAKESLAB)
The Singapore Manufacturing Federation (SMF) is a national body and industry association that works together with relevant partners to champion the interests and growth of our members and manufacturing community in Singapore; enhancing their competitiveness through capacity & capability development, innovation-led productivity growth, standards adoption & implementation, overseas expansion, and provides assistance and opportunities for companies to collaborate, network and expand locally and internationally; allowing members to enhance their competitiveness in the global arena.
The MedTech & Life Sciences Industry Group (MTLS), is one of the 10 industry groups in SMF. MTLS has been working towards its vision to be the leading voice for the medical technology industry. The group develops value-added programmes and seminars that cover a broad range of topics for its members. MTLS meets regularly to discuss industry-related issues, the latest updates on regulatory affairs, the impact of new regulations to the industry, business matters as well as the code of ethics.
The Association of Entrepreneurs for Laboratory and Health Equipment, also known as GAKESLAB (Gabungan Perusahaan Alat-Alat Kesehatan dan Laboratorium) was founded on May 6th, 1977 and has become the only association for the medical device and laboratory apparatus entrepreneurs in Indonesia.
The establishment of the association is facilitated by the Directorate General of Drug and Food Control- Ministry of Health of Indonesia (now has become the National Agency of Drug and Food Control) in order to ensure proper distribution of medical device in Indonesia and formalized in Ministry of Health Decision No. 216/Men.Kes/SK/IX/1977.
In general, GAKESLAB has the following roles to deliver:
• Providing capacity building and education for its members
• Supporting government program to ensure distribution of safe and good quality device (both local and imported products)
• Supporting government in developing related regulations, both at the strategic and technical level
• Supporting the development of local production and promoting locally produced Medical Device to international market
• Developing network with international stakeholders (other associations, foreign industries/ companies, foreign customers, etc.)
• Facilitating ethical business conduct among its members and related stakeholders
In order to perform the role in Indonesia effectively, GAKESLAB established provincial representative in each provinces. The first provincial representative was GAKESLAB DKI Jakarta, which was established on 1984. At the moment, GAKESLAB has already had 31 provincial representatives and 581 members as of July 2012. The members consist of MD industries, distributors, importers and after sales service providers.
GAKESLAB actively plays its roles by conducting regular meetings (at national and provincial levels), training, workshop and discussion forums with stakeholders. At the regional level, GAKESLAB was also instrumental in the establishment of former ASEAN Medical Device Association (AMDIA), which is replaced by ASEANMed.
Furthermore, GAKESLAB also actively reach out to other medical device associations to establish business network. GAKESLAB is currently working on establishing the code of conduct which will guide its members in conducting ethical business in Indonesia.
About Myanmar Pharmaceutical and Medical Equipment Entrepreneurs' Association (MPMEEA)
The Myanmar Pharmaceutical & Medical Equipment Entrepreneurs’ Association (MPMEEA), established in 1999, is a non-profit organization and non-Governmental Organization that serves to support and assist the State for success in its health care works. The MPMEEA works to improve manufacturing and import/export of medicine and medical equipment in accordance with the medical rules and regulations of the state. There are over 4000 members, which are entrepreneurs actively involved with pharmaceuticals, medical instruments, hospital equipment, and health-care consultancy. These members are manufacturers, traders, exporters, importers, wholesalers, retailers and etc. in the health-care business field. The MPMEEA guides its members on how to abide by the rules and regulations of the State, while at the same time improving public healthcare standard